Table 1.
Primary and secondary PK parameters of XM17 and Gonal-f®
| PK parametera | Statistic | XM17 (n = 36) | Gonal-f® (n = 36) |
|---|---|---|---|
| AUC0-t [IU∙h/L] | n | 36 | 36 |
| Mean (SD) | 632.0 (167.1) | 619.2 (191.1) | |
| Geom. mean | 605.3 | 589.0 | |
| Median | 647.5 | 598.5 | |
| Min-Max | 175–902 | 261–1131 | |
| Cmax [IU/L] | n | 36 | 36 |
| Mean (SD) | 9.18 (2.42) | 9.04 (2.49) | |
| Geom. mean | 8.85 | 8.70 | |
| Median | 9.07 | 8.81 | |
| Min-Max | 3.42–13.99 | 4.42–14.44 | |
| AUC0-168h [IU∙h/L] | n | 36 | 36 |
| Mean (SD) | 632.3 (167.0) | 620.3 (189.8) | |
| Geom. mean | 605.7 | 590.7 | |
| Median | 650.5 | 598.5 | |
| Min-Max | 176–902 | 264–1131 | |
| AUC0-∞ [IU∙h/L] | Ncalc | 15 | 15 |
| Mean (SD) | 665.6 (179.4) | 620.3 (208.6) | |
| Geom. mean | 641.2 | 583.6 | |
| Median | 647.4 | 622.9 | |
| Min-Max | 333–940 | 268–979 | |
| λZ [1/h] | Ncalc | 15 | 15 |
| Mean (SD) | 0.0258 (0.0164) | 0.0239 (0.0131) | |
| Geom. mean | 0.0229 | 0.0218 | |
| Median | 0.0201 | 0.0190 | |
| Min-Max | 0.0134–0.0736 | 0.0143–0.0663 | |
| tmax [h] | Ncalc | 36 | 36 |
| Mean (SD) | 19.78 (8.36) | 19.72 (7.92) | |
| Geom. mean | NAb | NAb | |
| Median | 16.00 | 16.00 | |
| Min-Max | 10.0–48.0 | 10.0–36.0 | |
| t1/2 [h] | Ncalc | 15 | 15 |
| Mean (SD) | 32.80 (11.12) | 33.73 (10.24) | |
| Geom. mean | 30.32 | 31.77 | |
| Median | 34.43 | 36.50 | |
| Min-Max | 9.41–51.54 | 10.45–48.38 | |
| CL/F [mL/min] | Ncalc | 15 | 15 |
| Mean (SD) | 8.13 (2.58) | 9.20 (3.91) | |
| Geom. mean | 7.80 | 8.57 | |
| Median | 7.72 | 8.03 | |
| Min-Max | 5.32–15.02 | 5.11–18.66 | |
| Vz/F [L] | Ncalc | 15 | 15 |
| Mean (SD) | 21.72 (7.00) | 24.38 (6.52) | |
| Geom. mean | 20.47 | 23.56 | |
| Median | 19.68 | 21.77 | |
| Min-Max | 6.7–36.9 | 13.8–35.7 |
AUC 0-168h area under the concentration-time curve from time 0–168 h postdose, AUC 0-∞ area under the concentration-time curve from time 0 to infinity, AUC 0-t area under the concentration-time curve from time 0 to the time of last observed concentration, CL/F apparent clearance, C max maximum concentration, λ Z apparent terminal rate constant, Geom. Mean, geometric mean, n number of participants within group, NA not applicable, N calc number of participants used for calculation, PK pharmacokinetic, SD standard deviation, t max time at which Cmax occurred, t 1/2 apparent half-life of terminal elimination, V z /F apparent volume of distribution during the terminal phase after extravascular administration
aAll values are corrected for predose FSH except for tmax
bGeometric mean is not meaningful for tmax.